CN115670610A

CN115670610A - Interatrial septum puncture device

Info

Publication number: CN115670610A
Application number: CN202211405869.5A
Authority: CN
Inventors: 高晗; 邱礼彪; 李安宁
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2022-11-10
Filing date: 2022-11-10
Publication date: 2023-02-03

Abstract

The invention relates to an interatrial septum puncture device, comprising: the handle shell is provided with an accommodating cavity; the proximal end of the sheath tube component extends into the accommodating cavity of the handle shell; the puncture needle is arranged in the sheath tube assembly in a penetrating way, and the puncture needle has a first state of being relatively fixed with the sheath tube assembly and a second state of axially moving relative to the sheath tube assembly under the driving of external force; the linkage mechanism is movably arranged in the accommodating cavity and comprises a first linkage component connected with the puncture needle; the first driving assembly is arranged on the handle shell and penetrates through the handle shell to be connected with the first linkage assembly; external force acts on the first driving assembly, and the first driving assembly drives the first linkage assembly to drive the puncture needle connected with the first linkage assembly to axially move relative to the sheath assembly, so that the far end of the puncture needle can extend out of the far end of the sheath assembly. The invention aims to provide an interatrial puncture device which can save operation time and reduce operation risk.

Description

Interatrial septum puncture device

Technical Field

The invention relates to the technical field of medical equipment, in particular to an interatrial septum puncture device.

Background

In some medical applications, it is often necessary to deliver medical devices to the left atrium for working, such as left atrial appendage occlusion, atrial fibrillation ablation, mitral valve replacement, etc., and to access the left atrium via the vessels connected to the left atrium, it is almost difficult to deliver the devices to the left atrium along these vessels due to the curved course of the vessels. Thus, the most common method used to access the left atrium is to advance medical devices to the right atrium via a venipuncture intervention and into the left atrium via an interatrial puncture.

The traditional interatrial septum puncture operation needs to be completed by the cooperation of two instruments, namely a puncture sheath and a puncture needle, the puncture sheath is firstly conveyed to an accurate position during the operation, then the puncture needle is conveyed into the body through the puncture sheath to perform puncture operation, and the far-end section of the puncture needle is of an inclined plane-shaped tip structure so as to puncture the interatrial septum easily.

In the existing device, because the puncture sheath and the puncture needle are arranged in a split mode, the puncture needle easily scratches the surface of the inner wall of the puncture sheath to generate debris in the process of conveying the puncture needle from the near end to the far end of the puncture sheath, and once the debris enters a blood vessel, thrombus can be possibly caused to damage a patient. And when a doctor manually advances the puncture needle to puncture the interatrial septum, the advancing distance of the puncture needle is uncontrollable, the puncture needle easily penetrates through the interatrial septum to enter the left atrium and then continuously moves forwards under the inertia effect to puncture the wall of the left atrium, so that the pericardium is stuffed, or the puncture needle punctures the aorta to cause serious complications and the like to damage patients. After the atrial septal puncture is completed, the atrial septal puncture is not fixed, further operation can be influenced due to relative movement of the atrial septal puncture and the atrial septal puncture, and the overall operation time is long and the risk is high due to the split type step-by-step operation mode.

Disclosure of Invention

In view of the above problems, the present invention aims to provide an interatrial septum puncture device that can save operation time and reduce operation risk.

The purpose is realized by the following technical scheme:

the invention provides an interatrial septum puncture device, which comprises:

a handle housing having an accommodating cavity;

a sheath assembly, a proximal end of the sheath assembly extending into the receiving cavity of the handle housing;

the puncture needle is arranged in the sheath tube assembly in a penetrating mode, and the puncture needle has a first state of being fixed relative to the sheath tube assembly and a second state of moving axially relative to the sheath tube assembly under the driving of external force;

the linkage mechanism is movably arranged in the accommodating cavity and comprises a first linkage component connected with the puncture needle;

the first driving assembly is arranged on the handle shell and penetrates through the handle shell to be connected with the first linkage assembly; external force acts on the first driving assembly, the first driving assembly drives the first linkage assembly to drive the puncture needle connected with the first linkage assembly to axially move relative to the sheath assembly, so that the far end of the puncture needle can extend out of the far end of the sheath assembly.

In some embodiments of the invention, the linkage further comprises:

the second linkage assembly is connected with the first driving assembly;

the near end of the sheath tube component is connected with the second linkage component, the near end of the puncture needle extends out of the near end of the sheath tube component and is connected with the first linkage component, and the first driving component drives the first linkage component and the second linkage component to link so as to drive the puncture needle and the sheath tube component to move reversely at the same time.

In some embodiments of the invention, the interatrial septum puncture device further comprises:

the clutch assembly is arranged on the handle shell and penetrates through the handle shell to be matched with the second linkage assembly;

the clutch assembly and the second linkage assembly have a first matching state and a second matching state,

in the first mating state, the second linkage assembly is separated from the sheath assembly;

in the second mating state, the second linkage assembly is connected with the sheath assembly.

In some embodiments of the invention, the first linkage assembly comprises:

the first transmission assembly is in transmission connection with the first driving assembly;

the first sliding piece is in sliding fit with the inner wall of the accommodating cavity and is connected with the first transmission assembly and the proximal end of the puncture needle, so that the first transmission assembly can drive the first sliding piece to slide, and the puncture needle connected with the first sliding piece is driven to move axially;

the second linkage assembly includes:

the second transmission assembly is in transmission connection with the first driving assembly;

the second sliding part is in sliding fit with the inner wall of the accommodating cavity and is connected with the second transmission assembly and the proximal end of the sheath assembly, so that the second sliding part can be driven by the second transmission assembly to slide, and the sheath assembly connected with the second sliding part is driven to move axially;

the first driving assembly drives the first transmission assembly and the second transmission assembly to be linked so as to drive the first sliding piece and the second sliding piece to move reversely at the same time;

the clutch assembly is provided with a matching piece, the second sliding piece is provided with a matching part matched with the matching piece, and the matching piece is matched with the matching part to realize the first matching state and the second matching state.

In some embodiments of the present invention, the first driving assembly comprises a driving gear, and the first sliding member is provided with a first threaded hole;

the first transmission assembly comprises a first driven gear and a first screw rod which are connected, the first screw rod is arranged in the first threaded hole in a penetrating mode and matched with the first threaded hole, and two ends of the first screw rod are respectively connected with the handle shell in a rotatable mode;

the second transmission assembly comprises a second driven gear, a second screw rod connected with the second driven gear and a transmission nut sleeved on the second screw rod, and two ends of the second screw rod are respectively and rotatably connected with the handle shell;

in the first matching state, the transmission nut is separated from the matching part through the matching piece;

and in the second matching state, the transmission nut is connected with the matching part through the matching part.

In some embodiments of the invention, the mating portion is a deformable jaw structure provided with a mating hole;

the matching piece is provided with a pin part which is in inserted matching with the matching hole;

under the first matching state, the pin part is inserted into the matching hole and props the jaw structure open, so that the jaw structure is separated from the transmission nut;

under the second cooperation state, the pin part is separated from the cooperation hole, and the jaw structure clamps the transmission nut.

In some embodiments of the present invention, the ratio of the number of teeth of the first driven gear and the second driven gear is 1 or more; and/or the ratio of the pitch of the second screw to the pitch of the first screw is greater than or equal to 1.

In some embodiments of the present invention, the clutch assembly further includes a positioning button, a connecting rod and an elastic member, the positioning button is located outside the accommodating cavity, one end of the connecting rod is connected to the positioning button, the other end of the connecting rod extends into the accommodating cavity and is connected to the mating member, the elastic member is sleeved on the connecting rod, one end of the elastic member abuts against the mating member, and the other end of the elastic member abuts against the inner wall of the accommodating cavity;

in the first fitting state, the elastic member applies an elastic force toward the fitting portion to the fitting piece.

In some embodiments of the present invention, the outer wall of the handle housing is provided with a first limiting groove and a second limiting groove which are recessed toward the mating portion, the position of the positioning knob can be switched between the first limiting groove and the second limiting groove, and the depth of the first limiting groove is greater than the depth of the second limiting groove;

under the first matching state, the positioning button is located in the first limiting groove, and under the second matching state, the positioning button is located in the second limiting groove.

In some embodiments of the invention, the sheath assembly comprises:

the lining is sleeved outside the puncture needle;

the insulation layer group is sleeved outside the lining;

an electrode assembly provided in the insulating layer group;

the distal end of the electrode lead is connected with the electrode component, and the proximal end of the electrode lead is used for externally connecting a mapping system device.

In some embodiments of the invention, the set of insulating layers comprises a first insulating layer, a second insulating layer, and a third insulating layer;

the electrode assembly includes a first electrode and a second electrode;

the first electrode cover is located outside the inside lining, second insulating layer cover is located outside the first electrode, the second electrode cover is located outside the second insulating layer, third insulating layer cover is located outside the second electrode, first insulating layer cover is located outside the inside lining, just the distal end on first insulating layer with the inside lining parallel and level, the near-end on first insulating layer with the distal end of first electrode offsets.

In some embodiments of the present invention, the insulation layer group includes a support layer and an insulation layer, the support layer is sleeved outside the liner, and the insulation layer is sleeved outside the support layer;

the electrode assembly comprises a first electrode and a second electrode, the first electrode and the second electrode are sleeved outside the insulating layer, and the first electrode and the second electrode are arranged at intervals;

the far end of the electrode lead is encapsulated in the insulating layer, and the near end of the electrode lead extends out of the near end of the insulating layer.

According to the interatrial septum puncture device, the sheath tube component and the puncture needle are integrally arranged, the puncture needle is accommodated in the sheath tube component, the far end of the puncture needle is close to the far end of the sheath tube component, and the puncture needle does not have the process from the near end to the far end of the sheath tube, so that the risk of thrombus caused by scraping the inner wall of the puncture needle to generate fragments is avoided. The puncture needle is driven by the first driving assembly and the first linkage assembly, so that the extending-in and extending-out distance of the puncture needle is accurate and controllable, and the puncture needle is prevented from continuously moving forwards after penetrating through the interatrial septum and entering the left atrium to puncture the left atrial wall, the aorta and other tissue structures; and the puncture needle and the sheath tube component can be relatively fixed, and the puncture needle has better stability in the operation process. In a further scheme, when the needle is withdrawn, the puncture needle and the sheath tube component can move reversely at the same time, the puncture needle moves towards the near end, and the sheath tube component moves forwards towards the far end, so that the puncture needle can be rapidly withdrawn into the sheath tube component; meanwhile, the puncture needle can provide stronger supporting force for the sheath assembly, so that the strength of the distal end of the sheath assembly is effectively ensured, the sheath assembly can quickly and easily penetrate through the atrial septum to form a reaming hole, and a sheath with a larger diameter can enter the sheath assembly; through this better scheme can one step operation accomplish fast narrowing and quick reaming simultaneously, reduced operation duration and reduced the operation risk.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like parts are designated by like reference numerals throughout the drawings. In the drawings:

FIG. 1 schematically illustrates a schematic structural view of a transseptal puncture device in accordance with an embodiment of the present invention;

FIG. 2 schematically illustrates a partial cross-sectional view of a handle housing according to an embodiment of the invention;

FIG. 3 schematically illustrates a cross-sectional structural view of a transseptal puncture device in accordance with an embodiment of the present invention;

fig. 4 schematically shows a partially enlarged schematic view of a portion a in fig. 3;

FIG. 5 schematically illustrates a connection of a handle housing to a linkage according to an embodiment of the invention;

FIG. 6 schematically illustrates a cross-sectional structural view of the handle housing and the second drive assembly, in accordance with an embodiment of the present invention;

FIG. 7 schematically illustrates a partial cross-sectional view of a septal puncture device in a first mating state in accordance with an embodiment of the present invention;

FIG. 8 schematically illustrates an enlarged partial view of portion B of FIG. 7;

FIG. 9 schematically illustrates a partial cross-sectional view of a septal puncture device in a second mating state in accordance with an embodiment of the present invention;

fig. 10 schematically shows a partial enlarged view of portion C of fig. 9;

fig. 11 schematically illustrates a structural view of a sheath assembly according to an embodiment of the present invention;

fig. 12 schematically shows a structural view of a sheath assembly according to another embodiment of the present invention;

fig. 13 schematically shows a structural view of a linkage mechanism according to an embodiment of the present invention.

The reference numbers are as follows:

100-a handle shell, 110-an accommodating cavity, 111-a first sliding groove, 112-a second sliding groove, 113-a first supporting part, 114-a second supporting part, 115-a third supporting part, 116-a fourth supporting part, 117-a bearing installation position, 101-a first limiting groove, 102-a second limiting groove, 103-a guide through groove, 104-an annular bulge, 105-a second annular groove, 106-a second scale, 107-an installation groove, 108-a first through hole, 109-an avoidance groove, 1091-a second spring limiting groove, 120-a bearing gland and 130-a wiring plug;

200-a first drive assembly, 210-a drive gear, 220-an adjustment knob;

300-linkage mechanism, 310-first linkage assembly, 311-first transmission assembly, 3111-first driven gear, 3112-first screw rod, 312-first sliding member, 3121-first threaded hole, 3122-first sliding portion, 3123-third through hole, 320-second linkage assembly, 321-second transmission assembly, 3211-second driven gear, 3212-second screw rod, 3213-transmission nut, 322-second sliding member, 3221-matching portion, 32211-first sub-claw, 32212-second sub-claw, 32213-matching hole, 3222-second sliding portion, 3223-second through hole, 32231-step structure, 3224-extension rod, 3225-luer joint, 3221-second sub-claw, 32213-matching hole, 3222-second sliding portion, 3223-second through hole, 32231-step structure, 3224-extension rod, 3225-luer joint,

330-crank, 331-first articulation, 332-second articulation, 340-first link, 350-second link;

400-sheath assembly, 410-liner, 420-insulation layer group, 421-first insulation layer, 422-second insulation layer, 4221-second boss structure, 423-third insulation layer, 424-support layer, 425-insulation layer, 430-electrode assembly, 431-first electrode, 4311-first boss structure, 432-second electrode, 4321-third boss structure, 440-electrode lead;

500-clutch component, 510-mating piece, 511-pin part, 512-first spring limit groove, 520-positioning button, 521-second threaded hole, 530-connecting rod and 540-elastic piece;

600-a second driving component, 610-an adjusting nut, 611-a first annular groove, 612-a first scale, 620-an adjusting slider, 621-a guide boss and 622-a first through hole;

700-puncture needle;

800-pulling rope.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For convenience in description, the relationship of one element or feature to another element or feature as illustrated in the figures may be described herein using spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "over", and the like. This spatially relative term is intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "in 8230 \8230; below" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

It should be noted that "distal" and "proximal" are used as terms of orientation that are commonly used in the field of interventional medical devices, wherein "distal" refers to the end that is distal from the operator during the procedure, and "proximal" refers to the end that is proximal to the operator during the procedure. Axial, meaning a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device; radial, means a direction perpendicular to the above-mentioned axial direction.

Referring to fig. 1, 3 and 7, a transseptal puncture device is provided according to an embodiment of the present invention.

The interatrial septum puncture device comprises: a handle housing 100, a first drive assembly 200, a linkage 300, a sheath assembly 400, and a puncture needle 700. Illustratively, the handle housing 100 has a cylindrical shape, the interior of the handle housing 100 is hollow to form an accommodating cavity 110, the linkage mechanism 300 is disposed in the accommodating cavity 110, and the sheath assembly 400 and the proximal portion of the puncture needle 700 are both disposed through the accommodating cavity 110. The sheath assembly 400 is sleeved outside the puncture needle 700, the inner diameter of the sheath assembly 400 is larger than the outer diameter of the puncture needle 700, the puncture needle 700 has a first state of being relatively fixed with the sheath assembly 400 and a second state of axially moving relative to the sheath assembly 400 under the driving of external force, the distal end of the puncture needle 700 is arranged in the sheath assembly 400 and close to the distal end of the sheath assembly 400, in the intervention process of an apparatus, the sheath assembly 400 and the puncture needle 700 are integrally inserted into a blood vessel or a ventricle of a patient, in the insertion process, the sheath assembly 400 and the puncture needle 700 do not move relatively, the puncture needle 700 is accommodated in the sheath assembly 400, the distal end of the puncture needle is close to the distal end of the sheath assembly 400, and the puncture needle 700 does not have the process from the proximal end to the distal end of the sheath assembly 400, so that the risk of thrombus caused by scraping the inner wall to generate debris does not exist, and the safety of the operation is improved; meanwhile, the sheath tube assembly 400 and the puncture needle 700 enter simultaneously in the mode, step-by-step operation is not needed, and operation time is greatly saved.

The linkage mechanism 300 includes a first linkage assembly 310 connected to the puncture needle 700, the first driving assembly 200 is disposed on the handle housing 100 and passes through the handle housing 100 to be connected to the first linkage assembly 310, an external force acts on the first driving assembly 200, for example, the first driving assembly 200 is driven by a manual operation or a motor, and the first driving assembly 200 drives the first linkage assembly 310 to drive the puncture needle 700 connected to the first linkage assembly 310 to move axially relative to the sheath assembly 400, so that the distal end of the puncture needle 700 can extend out of the distal end of the sheath assembly 400. In this embodiment, the puncture needle 700 is driven by the first driving assembly 200 and the first linkage assembly 310, so that the extending and retracting distance of the puncture needle 700 is precise and controllable, and the puncture needle is prevented from continuously moving forward to puncture the left atrial wall, the aorta and other tissue structures after penetrating through the interatrial septum and entering the left atrium. And the puncture needle and the sheath tube component can be relatively fixed, and the puncture needle has better stability in the operation process.

In some embodiments of the present invention, as shown in fig. 7, the linkage mechanism 300 further includes a second linkage assembly 320. Specifically, the proximal end of the puncture needle 700 extends from the proximal end of the sheath assembly 400 such that the proximal end of the puncture needle 700 is disposed on the proximal side with respect to the sheath assembly 400. Wherein the first linkage assembly 310 and the second linkage assembly 320 are both movable within the accommodating chamber 110, the first linkage assembly 310 is disposed near the proximal end with respect to the second linkage assembly 320, the first linkage assembly 310 is connected to the proximal end of the puncture needle 700, and the second linkage assembly 320 is connected to the proximal end of the sheath assembly 400. The first driving assembly 200 is movably disposed on the handle housing 100, the first linkage assembly 310 and the second linkage assembly 320 are both in transmission connection with the first driving assembly 200, and the first linkage assembly 310 and the second linkage assembly 320 are driven by the first driving assembly 200 to respectively drive the puncture needle 700 and the sheath assembly 400 to reversely move in a linkage manner. For example, the second driving assembly 600 drives the proximal end of the sheath assembly 400 to move towards the side away from the proximal end of the sheath assembly 400, that is, the proximal end of the sheath assembly 400 and the proximal end of the puncture needle 700 move back to back, so that the distal end of the puncture needle 700 is advanced forwards while retracting towards the inside of the sheath assembly 400, and thus the stroke distance of the puncture needle 700 outside the sheath assembly 400 during the retraction process of the puncture needle 700 is shortened, the puncture needle 700 can be quickly retracted into the sheath assembly 400, the retraction speed is high, and the risk of accidental injury of the puncture needle 700 is reduced. When the needle is withdrawn, the puncture needle and the sheath tube component can move reversely at the same time, the puncture needle moves towards the near end, and the sheath tube component advances towards the far end, so that the puncture needle can be quickly withdrawn into the sheath tube component; meanwhile, the puncture needle provides stronger supporting force, the strength of the distal end of the sheath tube assembly is effectively guaranteed, the sheath tube assembly can quickly and easily penetrate through the atrial septum to form a reaming hole, and accordingly the subsequent sheath tube with a larger diameter can enter conveniently.

It should be noted that, as shown in fig. 7 and 13, the moving directions of the proximal end of the puncture needle 700 and the proximal end of the sheath assembly 400 are not limited in this embodiment, and the sheath assembly 400 and the puncture needle 700 may be bent according to actual requirements, so that the technical effects of retracting the distal end of the puncture needle 700 and advancing the distal end of the sheath assembly 400 can be achieved as long as the proximal end of the puncture needle 700 and the proximal end of the sheath assembly 400 move back to the back. Understandably, on the basis of this, the linkage mechanism 300 can select different structural forms, which can be a screw-nut mechanism, a combination of the screw-nut mechanism and a rhombic four-bar mechanism, a crank-slider mechanism, and can also be a bidirectional hydraulic cylinder mechanism with two piston rods arranged in opposite directions. It is within the scope of the present invention for the linkage mechanism 300 to include two modules or structures that move in a back-to-back direction and are connected to the proximal end of the introducer needle 700 and the proximal end of the sheath assembly 400, respectively, to enable the proximal end of the sheath assembly 400 and the proximal end of the introducer needle 700 to move in a back-to-back direction.

In this embodiment, the proximal end of the sheath assembly and the proximal end of the puncture needle are moved in the opposite directions, that is, the proximal ends of the sheath assembly and the puncture needle are moved away from each other. The opposite movement means that the sheath assembly and the puncture needle move in the direction of approaching each other, and the proximal end of the sheath assembly and the proximal end of the puncture needle move in the opposite direction, that is, the proximal end of the sheath assembly and the proximal end of the puncture needle approach each other. The reverse movement includes both the backward movement and the forward movement.

In some embodiments of the present invention, as shown in fig. 7-10, the transseptal puncture device further comprises: and the clutch assembly 500 is arranged on the handle shell 100, penetrates through the handle shell 100 and is matched with the second linkage assembly 320. The clutch assembly 500 and the second linkage assembly 320 have a first mating state and a second mating state; in the first engagement state, the second linkage assembly 320 is separated from the sheath assembly 400, such that in the first engagement state, when the first driving assembly 200 drives the first transmission assembly 311 and the second transmission assembly 321 to engage, the sheath assembly 400 remains stationary relative to the interatrial septum, while the first linkage assembly pushes the puncture needle 700 to move distally, thereby extending the distal end of the puncture needle 700 from the distal end of the sheath assembly 400 and puncturing the interatrial septum to complete the puncturing action. In the second matching state, the second linkage assembly 320 is connected to the sheath assembly 400, and when the first driving assembly 200 drives the first transmission assembly 311 and the second transmission assembly 321 to link, the distal end of the sheath assembly 400 extends forward (in the distal direction) and the distal end of the puncture needle 700 retracts backward (in the proximal direction), so that the stroke distance of the puncture needle 700 outside the sheath assembly 400 during the retraction process of the puncture needle 700 is shortened, and the needle retraction speed is high. The setting of clutch assembly 500 makes in the puncture process, and under first cooperation state, sheath subassembly 400 keeps butt interatrial space, and pjncture needle 700 advances relative to sheath subassembly 400, and pjncture needle 700 does not receive the influence of sheath subassembly 400, and advancing process is controllable simultaneously, and the pjncture needle can not pierce the left atrium wall because of inertia. And in the process of needle withdrawing after the puncture, the sheath tube assembly 400 advances when the puncture needle is withdrawn in the second state, so that the puncture needle can be quickly withdrawn into the sheath tube assembly 400, the operation time is saved, and meanwhile, the risk of puncture accidental injury in the needle withdrawing process is avoided. Meanwhile, the puncture needle provides stronger supporting force, the strength of the distal end of the sheath tube assembly is effectively guaranteed, the sheath tube assembly can quickly and easily penetrate through the atrial septum to form a reaming hole, and accordingly the subsequent sheath tube with a larger diameter can enter conveniently.

In some embodiments of the present invention, as shown in fig. 5, 7 and 9, the first linkage assembly 310 includes a first transmission assembly 311 and a first sliding member 312, the second linkage assembly 320 includes a second transmission assembly 321 and a second sliding member 322, in detail, the first transmission assembly 311 and the second transmission assembly 321 are both in transmission connection with the first driving assembly 200, the first sliding member 312 is connected with the first transmission assembly 311, the second sliding member 322 is connected with the second transmission assembly 321, the first transmission assembly 311 transmits the power output by the first driving assembly 200 to the first sliding member 312 to drive the first sliding member 312 to slide in the accommodating cavity 110, and the second transmission assembly 321 transmits the power output by the first driving assembly 200 to the second sliding member 322 to drive the second sliding member 322 to slide in the accommodating cavity 110. Since the first transmission assembly 311 and the second transmission assembly 321 are in transmission connection with the first transmission member, when the first driving assembly 200 outputs power, the first slider 312 and the second slider 322 can be ensured to slide simultaneously, and the first slider 312 and the second slider 322 can move in opposite directions under the driving of the first driving assembly 200 by symmetrically arranging the first linkage assembly 310 and the second linkage assembly 320 on both sides of the first driving assembly 200, respectively. The first slider 312 is connected to the proximal end of the puncture needle 700, the second slider 322 is connected to the proximal end of the sheath assembly 400, and both the first slider 312 and the second slider 322 are slidably engaged with the inner wall of the accommodating chamber 110, so that the first slider 312 and the second slider 322 can move axially under the restriction of the inner wall of the accommodating chamber 110, so as to more precisely restrict the moving direction of the sheath assembly 400 and the puncture needle 700, and the moving direction of the sheath assembly 400 and the puncture needle 700 is parallel to the axial direction thereof, so that the relative movement process of the puncture needle 700 and the sheath assembly 400 can be smoother.

It should be noted that the reverse movement includes a facing movement and a back movement. When the first slider 312 and the second slider 322 are moved toward each other, the distal end of the sheath assembly 400 is retracted proximally relative to the puncture needle 700, and the distal end of the puncture needle 700 is extended distally relative to the sheath assembly 400, so that the distal end of the puncture needle 700 is extended from the distal end of the sheath assembly 400, to perform the interatrial septum puncture action. As the first and

second sliders

312, 322 move back to back, the distal end of the sheath assembly 400 is advanced distally relative to the needle 700, and the distal end of the needle 700 is retracted proximally relative to the sheath assembly 400, retracting the distal end of the needle 700 within the sheath assembly 400 for simultaneous retracting and reaming.

In some embodiments of the present invention, please refer to fig. 1, fig. 8 and fig. 10, for example, the clutch assembly 500 is disposed on the handle housing 100 corresponding to the second slider 322, the clutch assembly 500 has a matching member 510, the second slider 322 has a matching portion 3221 matched with the matching member 510, and the matching member 510 and the matching portion 3221 have a first matching state and a second matching state. In the first fitting state, the second sliding member 322 is stationary relative to the handle housing 100, and in the second fitting state, the second sliding member 322 can slide relative to the handle housing 100 under the driving of the second transmission assembly 321.

Understandably, the transition between the second slider 322 and the handle housing 100 between the relatively stationary state and the relatively sliding state is controlled by the clutch assembly 500. Alternatively, when the puncture needle 700 is extended distally to perform a puncturing action, and the engaging element 510 and the engaging portion 3221 are configured to be in the first engaging state, the sheath assembly 400 remains stationary due to the second slider 322 being stationary relative to the handle housing 100, and the first slider 312 pushes the puncture needle to move distally, so that the distal end of the puncture needle is extended from the distal end of the sheath assembly 400, and the atrial septum is punctured, to complete the puncturing action. When the puncture needle is moved back to perform a needle retracting action, the first driving assembly 200 drives the first transmission assembly 311 and the second transmission assembly 321 to be linked, so that the first slider 312 and the second slider 322 move back to back, and at this time, the matching element 510 and the matching portion 3221 are configured into the second matching state, so that the second slider 322 can slide relative to the handle housing 100, and in the state that the proximal end of the sheath assembly 400 and the proximal end of the puncture needle 700 move back to back, the distal end of the puncture needle 700 is retracted while the distal end of the sheath assembly 400 is extended, thereby shortening the stroke distance of the puncture needle 700 outside the sheath assembly 400 during the retraction of the puncture needle 700, and realizing quick needle retraction. And meanwhile, the puncture needle provides stronger supporting force, so that the strength of the distal end of the sheath assembly is effectively ensured, the sheath assembly can quickly and easily penetrate through the atrial septum to form a reaming hole, and the subsequent sheath with larger diameter can enter conveniently. This mode accessible one-step operation has realized removing needle and reaming simultaneously, and it is faster to remove the needle, and the reaming is quick easier.

There may be various ways of cooperation between the clutch assembly 500 and the second slider 322 to change the relative state between the second slider 322 and the handle housing 100. For example, the engaging portion may be a hole structure provided in the second sliding member, the clutch assembly is a pin-shaped connecting member, in the first engaging state, the pin-shaped connecting member is simultaneously inserted into the handle housing and the second sliding member, and the pin-shaped connecting member connects the second sliding member and the handle housing as a whole, so that the second sliding member and the handle housing are kept stationary. In the second mating state, the pin-shaped connector is pulled out of the hole-shaped structure of the second slider, so that the second slider can slide relative to the handle housing. Understandably, the engaging relationship of the clutch assembly and the second sliding member can be arranged in other forms.

The technical solution of the present invention will be described in further detail with reference to specific embodiments.

Implementation mode one

In the present embodiment, as shown in fig. 3 and 7, the linkage mechanism 300 is a two-screw-nut mechanism disposed in opposite directions, and by converting the rotation of the screw into the linear motion of the nut, the first slider 312 serves as one of the nuts, and the second slider 322 is connected to the other nut structure, so that the opposite movement of the first slider 312 and the second slider 322 is achieved by driving the rotation of the two screws.

In detail, the sheath assembly 400, the puncture needle 700 and the linkage mechanism 300 are all installed in the accommodating chamber 110 of the handle housing 100, and the axis of the handle housing 100 coincides with the axis of the sheath assembly 400 and the puncture needle 700. Please refer to fig. 2 and 5, the first driving assembly 200 includes an adjusting knob 220 and a driving gear 210, the outer wall of the handle casing 100 is provided with an installation slot 107 for accommodating the adjusting knob, a first through hole 108 penetrating through the handle casing 100 is formed in a bottom wall of the installation slot 107, the adjusting knob 220 includes an adjusting body rotatably disposed in the installation slot 107 and a rod-shaped connecting portion connected to the adjusting body, the rod-shaped connecting portion extends into the accommodating cavity 110 through the first through hole 108 and is connected to the driving gear 210 disposed in the accommodating cavity 110, the installation slot 107 is mainly used for accommodating the adjusting body, so that the adjusting body sinks integrally with respect to the handle casing 100, and the probability of mistakenly touching the adjusting knob 220 is reduced.

Referring to fig. 2, fig. 5 and fig. 6 again, the first transmission assembly 311 includes a first driven gear 3111 and a first screw 3112 connected to each other, the second transmission assembly 321 includes a second driven gear 3211, a second screw 3212 and a transmission nut 3213, the second driven gear 3211 is connected to the second screw 3212, and the transmission nut 3213 is sleeved on the second screw 3212 and is in threaded engagement with the second screw 3212. The handle housing 100 is provided with a first supporting portion 113, a second supporting portion 114, a third supporting portion 115 and a fourth supporting portion 116 which protrude from the inner wall of the accommodating chamber 110 and are sequentially arranged at intervals along the axial direction of the handle housing 100 from the proximal end to the distal end. The drive gear 210, the first driven gear 3111 and the second driven gear 3211 are located between the second support portion 114 and the third support portion 115, both ends of the first screw 3112 are respectively rotatably provided on the first support portion 113 and the second support portion 114, both ends of the second screw 3212 are respectively rotatably provided on the third support portion 115 and the fourth support portion 116, the first screw 3112 is located on a proximal side with respect to the second screw 3212, and an axis of the first screw 3112 and an axis of the second screw 3212 are coincident with each other and parallel to an axis of the handle housing 100. The first sliding member 312 has a first threaded hole 3121 engaged with the first screw 3112, the first screw 3112 penetrates through the first threaded hole 3121 and is engaged with the first threaded hole 3121, the first driven gear 3111 and the second driven gear 3211 are both engaged with the driving gear 210, the adjusting knob 220 is manually rotated to drive the first screw 3112 to rotate around its own axis in the accommodating cavity 110 through the driving gear 210 and the first driven gear 3111, so as to drive the first sliding member 312 to move along the axis of the first screw 3112, and meanwhile, the driving gear 210 further drives the second driven gear 3211 to rotate, so that the second screw 3212 rotates around its own axis in the accommodating cavity 110, and further drives the transmission nut 3213 to move along the axis of the second screw 3212.

In the present embodiment, as shown in fig. 5, since the driving gear 210, the first driven gear 3111 and the second driven gear 3211 are both bevel gears, when the driving gear 210 rotates in one direction, the rotation directions of the first driven gear 3111 and the second driven gear 3211 are opposite, and further the rotation directions of the first screw 3112 and the second screw 3212 are opposite, and the screw directions of the first screw 3112 and the second screw 3212 are the same, so that the first screw 3112 and the second screw 3212 rotate in opposite directions to drive the transmission nut 3213 and the first slider 312 to move in opposite directions.

In other embodiments, the driving gear, the first driven gear and the second driven gear may be spur gears (not shown in the figures), when the driving gear rotates in a certain direction, the first driven gear and the second driven gear rotate in the same direction, so that the first screw rod and the second screw rod rotate in the same direction, and the screw threads of the first screw rod and the second screw rod rotate in opposite directions (not shown in the figures), so that the transmission nut and the first sliding member move in opposite directions.

As shown in fig. 7 and 8, in the first engaging state, the transmission nut 3213 is separated from the engaging portion 3221 by the engaging element 510, so that the transmission nut 3213 is separated from the second slider 322, and when the transmission nut 3213 moves axially under the driving of the second screw 3212, the second slider 322 is not influenced by the driving force of the first driving assembly 200, and the second slider 322 and the handle housing 100 remain stationary. Therefore, in the first engagement state, the adjustment nut 610 can be rotated to move the first slider 312 and the transmission nut 3213 toward each other, and in a state where the second slider 322 is held stationary with respect to the handle housing 100, the first slider 312 is moved distally to hold the sheath assembly 400 stationary and move the puncture needle 700 distally to extend the distal end of the puncture needle 700 out of the sheath to perform an interatrial puncture action.

Referring to fig. 9 and 10, in the second engagement state, the transmission nut 3213 is connected to the engagement portion 3221 through the engagement member 510, so that the transmission nut 3213 and the second sliding member 322 are connected to form a whole, and when the transmission nut 3213 moves axially under the driving of the second screw 3212, the transmission nut drives the second sliding member 322 to move relative to the handle housing 100. Thus, in the second mating condition, the first slider 312 and the second slider 322 may be moved back to back by turning the adjustment nut 610 to perform the retracting and reaming actions simultaneously.

It should be noted that, in the present embodiment, the connection state between the transmission nut 3213 and the engagement portion 3221 is changed by the engagement piece 510 to change the relative state between the second slider 322 and the handle housing 100.

Understandably, in other embodiments, the engaging member may be a connecting member (not shown) for integrally connecting the transmission nut and the second sliding member, and in the first engaging state, the engaging member is disengaged from the engaging portion of the second sliding member or the transmission nut to disengage the transmission nut from the second sliding member. Under the second cooperation state, the fitting piece links to each other with second slider and drive nut respectively to be connected as an organic whole with the two. For example, a slot structure (not shown) is provided on the second sliding member, the mating member includes a snap structure engaged with the slot structure and a groove structure engaged with the transmission nut, in the first engagement state, the transmission nut is snapped into the groove structure, and the snap structure is inserted into the slot structure, thereby connecting the transmission nut and the second sliding member into a whole. It is understood that the fitting manner between the fitting member and the transmission nut and the fitting portion may be other manners, and it is within the protection scope of the present invention as long as the fitting member can be detachably connected with the transmission nut and the fitting portion.

In this embodiment, referring to fig. 2 and 5, in order to reduce the rotation resistance of the first screw 3112 and the second screw 3212, the first support portion 113, the second support portion 114, the third support portion 115 and the fourth support portion 116 are all provided with a rotation bearing, and two ends of the first screw 3112 are arranged in a cylindrical structure, so that two ends of the first screw 3112 are respectively embedded into inner rings of the rotation bearings on the first support portion 113 and the second support portion 114. Both ends of the second screw rod 3212 are also provided with a cylindrical structure so that both ends of the second screw rod 3212 are respectively embedded in the inner rings of the rotary bearings on the third and fourth supporting

portions

115 and 116.

Specifically, bearing mounting positions 117 are respectively arranged on the first supporting portion 113, the second supporting portion 114, the third supporting portion 115 and the fourth supporting portion 116, the axes of the four bearing mounting positions 117 are overlapped, the four bearing mounting positions 117 are distributed on two sides of the adjusting knob 220, and the bearings are arranged on the bearing mounting positions 117 and are pressed and fixed through the bearing pressing covers 120.

In an exemplary embodiment, as shown in fig. 8 and 10, the matching portion 3221 is a deformable claw structure, the claw structure is provided with a substantially U-shaped structure, and includes a first sub-claw 32211 and a second sub-claw 32212 which are oppositely arranged, the driving nut 3213 is provided between the first sub-claw 32211 and the second sub-claw 32212, each of the first sub-claw 32211 and the second sub-claw 32212 is provided with a matching hole 32213, the matching member 510 has a pin portion 511 which is in plug-fit with the matching hole 32213, the pin portions 511 are provided in two symmetrical shapes, and each pin portion 511 corresponds to one matching hole 32213. In the first engagement state, the pin portion 511 is inserted into the engagement hole 32213 and spreads the first sub-latch claw 32211 and the second sub-latch claw 32212 apart, so that the claw structure is separated from the driving nut 3213. In the second engagement state, the pin portion 511 is separated from the engagement hole 32213, and the first and second

sub-latch claws

32211 and 32212 elastically recover and grip the driving nut 3213.

In this embodiment, the engaging hole 32213 is configured as a waist-shaped hole, the cross section of the waist-shaped hole has two opposite circular arc edges and a straight edge connecting the two circular arc edges, the length direction of the straight edge is the moving direction of the first sub-card claw 32211 and the second sub-card claw 32212, and the waist-shaped hole is engaged with the clutch assembly 500, so as to achieve axial positioning and fixing of the second sliding member 322, and ensure that the axial position of the second sliding member 322 is unchanged in the process of gradually closing the jaw structure to fix the transmission nut 3213.

In the present embodiment, as shown in fig. 8 and 10, the clutch assembly 500 includes a positioning knob 520, a connecting rod 530, a fitting member 510, and an elastic member 540. The positioning button 520 is located outside the accommodating cavity 110, one end of the connecting rod 530 is connected to the positioning button 520, the other end of the connecting rod 530 extends into the accommodating cavity 110 and is connected to the mating member 510, the elastic member 540 is sleeved on the connecting rod 530, one end of the elastic member 540 abuts against the mating member 510, the other end of the elastic member 540 abuts against the inner wall of the accommodating cavity 110, in a first mating state, the elastic member 540 applies an elastic force towards the mating member 510 towards the mating portion 3221, so as to ensure that the mating member 510 can be stably pressed on the jaw structure, and ensure that the transmission nut 3213 is disengaged from the jaw structure.

In this embodiment, as shown in fig. 8, the elastic member 540 is a spring, the connecting rod 530 and the mating member 510 are integrally formed, the connecting rod 530 is hollow, a second threaded hole 521 is formed in an end surface of the positioning button 520 facing the mating member 510, and a screw is inserted through the hollow structure of the connecting rod 530 and is engaged with the second threaded hole 521 to fixedly connect the positioning button 520 and the mating member 510. The fitting piece 510 is provided with a first spring limiting groove 512 on one side end face of the positioning button 520, a second spring limiting groove 1091 is provided on the inner wall of the accommodating cavity 110 of the handle casing 100, two ends of the spring are respectively provided in the first spring limiting groove 512 and the second spring limiting groove 1091, and two ends of the spring respectively abut against the bottom wall of the first spring limiting groove 512 and the bottom wall of the second spring limiting groove 1091. The distance between the bottom wall of the first spring retaining groove 512 and the bottom wall of the second spring retaining groove 1091 is smaller than the natural length of the spring, so that the spring is in a compressed state, thereby providing the engaging member 510 with an elastic force toward the engaging portion 3221.

Further, as shown in fig. 8 and 10, the outer wall of the handle housing 100 is provided with a first limiting groove 101 and a second limiting groove 102 recessed toward the matching portion 3221, the first limiting groove 101 and the second limiting groove 102 are both in a strip shape, the first limiting groove 101 is perpendicular to and intersects with the second limiting groove 102, and the profiles of the first limiting groove 101 and the second limiting groove 102 are both matched with the positioning button 520, so that the position of the positioning button 520 can be switched between the first limiting groove 101 and the second limiting groove 102. When the positioning button 520 is located in the first retaining groove 101, the engaging element 510 and the engaging portion 3221 are in the first engaging state. When the positioning button 520 is located in the second retaining groove 102, the engaging element 510 and the engaging element 3221 are in a second engaging state.

The depth of the first limiting groove 101 is greater than the depth of the second limiting groove 102, an avoiding groove 109 is further formed in the inner wall of the accommodating cavity 110 corresponding to the fitting piece 510, and the depth of the avoiding groove 109 is greater than the difference between the groove depths of the first limiting groove 101 and the second limiting groove 102. The difference between the groove depths of the first limiting groove 101 and the second limiting groove 102 is the movement stroke of the clutch assembly 500.

Specifically, as shown in fig. 8 and 10, the clutch assembly 500 operates as: when the slider is separated, the positioning button 520 is located in the first limiting groove 101, the mating member 510 is located at an opening between the first sub-card claw 32211 and the second sub-card claw 32212, the pin portion 511 is inserted into the mating hole 32213, the first sub-card claw 32211 and the second sub-card claw 32212 are spread apart, the transmission nut 3213 is not contacted with the pin portion 511, and meanwhile, the pin portion 511 is matched with the mating hole 32213, so that the position of the second sliding block is fixed. When in connection, the positioning button 520 is pulled outwards and rotated by 90 °, at this time, the positioning button 520 is located in the second limiting groove 102, the mating member 510 withdraws from the first sub-card claw 32211 and the second sub-card claw 32212, the pin portion 511 withdraws from the mating hole 32213, and the first sub-card claw 32211 and the second sub-card claw 32212 are closed and fixedly connected with the driving nut 3213. Since the length of the pin portion 511 is greater than the thickness of the main body of the fitting member 510 and the fitting hole 32213 is a kidney-shaped hole, when the positioning button 520 is pulled out, the pin portion 511 can be ensured to be in a fitting state with the fitting hole 32213 before the claw structures are completely closed, and the position of the second slider 322 can be kept fixed.

In some embodiments, as shown in fig. 5 and 6, the inner wall of the accommodating cavity 110 is provided with a first sliding groove 111 and a second sliding groove 112, a length direction of the first sliding groove 111 and a length direction of the second sliding groove 112 are both parallel to an axial direction of the handle housing 100, the first sliding member 312 is provided with a first sliding portion 3122 in sliding fit with the first sliding groove 111, and the second sliding member 322 is provided with a second sliding portion 3222 in sliding fit with the second sliding groove 112. The first sliding groove 111 and the second sliding groove 112 are sized to fit the sheath assembly 400, and the number is determined by the number of the first sliding portion 3122 and the second sliding portion 3222, and the length direction is the axial direction of the handle housing 100. The moving direction of the first slider 312 is defined by the engagement of the first sliding portion 3122 with the first sliding groove 111, so that the first slider 312 has only a freedom of movement along the axis, and the first slider 312 is restricted from having a freedom in the radial direction. Similarly, the cooperation of the second sliding portion 3222 and the second sliding slot 112 is used for defining the moving direction of the second slider 322, so that the second slider 322 has only freedom to move along the axis, and limits the freedom of the second slider 322 along the radial direction.

In this embodiment, in order to further shorten the stroke distance of the puncture needle 700 outside the sheath assembly 400 during retraction, the first driven gear 3111 and the second driven gear 3211 are set to have different numbers of teeth, so that the ratio of the numbers of teeth of the first driven gear 3111 and the second driven gear 3211 is greater than or equal to 1, or the first screw 3112 and the second screw 3212 are set to have different pitches, so that the ratio of the pitch of the second screw 3212 to the pitch of the first screw 3112 is greater than or equal to 1, thereby realizing different transmission ratios, and making the stroke of the puncture needle 700 during retraction smaller than the stroke of the sheath assembly 400 during advancement, thereby shortening the stroke distance of the puncture needle 700 outside the sheath assembly 400 during retraction.

For example, if the ratio of the number of teeth of the first driven gear 3111 and the second driven gear 3211 of the first-stage transmission is a, the first screw 3112 and the second screw 3212 are set to different pitches, and the ratio of the pitches of the second screw 3212 and the first screw 3112 is b, it can be achieved that the first slider 312 and the second slider 322 exhibit different sliding speeds when the adjustment knob 220 is rotated, and the speed ratio is a multiplied by b. For example, the gear ratio of the first driven gear 3111 and the second driven gear 3211 is 2, and the pitch ratio of the second screw 3212 and the first screw 3112 is 3, the sliding speed of the second slider 322 in the axial direction is 6 times that of the first slider 312, the puncture needle 700 is retracted by 1mm, and the sheath assembly 400 can advance by 6mm, which is beneficial to achieving precise control of the puncture needle 700 in clinic, and shortening the stroke distance outside the sheath assembly 400 during retraction of the puncture needle 700, achieving rapid retraction of the puncture needle 700, and avoiding cardiac perforation.

Understandably, the values of a and b can also be set to other values, which are not limited herein.

It should be emphasized that, by means of gear engagement and thread adjustment, the extending position and the extending distance of the puncture needle 700 can be made accurate and controllable, and the condition that the puncture needle 700 continues to move forward to pierce the left atrial wall to cause pericardial tamponade or pierce the aorta to cause serious complications and the like to harm the patient when the puncture needle 700 is pushed manually by the doctor in the existing device after penetrating through the interatrial septum and entering the left atrium due to inertia is avoided.

In this embodiment, as shown in fig. 3 and 6, the interatrial septum puncture device further comprises a second driving assembly 600 and a pulling rope 800, wherein the second driving assembly 600 is movably disposed on the handle housing 100, a portion of the pulling rope 800 near the distal end is inserted into the interlayer of the sheath assembly 400, the distal end of the pulling rope 800 is fixed to the distal end of the sheath assembly 400, and the proximal end of the pulling rope 800 is connected to the second driving assembly 600. The second drive assembly 600 is capable of driving the proximal end of the pull-cord 800 to move to pull or release the pull-cord 800, the distal end of the sheath assembly 400 bending when the second drive assembly 600 pulls on the pull-cord 800, and the distal end of the sheath assembly 400 returning to straight when the second drive assembly 600 releases the pull-cord 800. Therefore, when the initial bending angle of the puncture needle 700 after entering the right atrium is not good, the distal end of the sheath assembly 400 is bent by a proper angle by adjusting the second driving assembly 600 to adjust the puncture angle of the puncture needle 700, and the puncture needle 700 does not need to be withdrawn to perform angle molding on the puncture needle 700 again, so that the position precision of the puncture needle 700 is improved on one hand, and the operation time is saved on the other hand.

Understandably, the bending degree of the sheath assembly 400 is related to the proximal moving distance of the traction rope 800, so that the moving distance of the proximal end of the traction rope 800 can be precisely controlled by the second driving assembly 600 to precisely control the bending degree of the sheath assembly 400, thereby obtaining a better puncturing angle.

It should be noted that the second driving assembly can be provided in various configurations, for example, in some possible embodiments, the second driving assembly includes a cylindrical body (not shown) rotatably disposed in the receiving cavity and a handle (not shown) located outside the receiving cavity and capable of driving the cylindrical body to rotate, the proximal end of the traction rope is wound around the cylindrical body, and the handle drives the cylindrical body to rotate so that the traction rope is wound around or released from the cylindrical body to adjust the tightness of the traction rope. Understandably, the second drive assembly could also be provided in other forms as long as the proximal end of the pull-cord can be moved to vary the tension of the pull-cord.

In an exemplary embodiment, as shown in fig. 3 and 6, the second driving assembly 600 includes an adjusting nut 610 and an adjusting slider 620, the adjusting nut 610 is rotatably sleeved on the handle housing 100, an axis of the adjusting nut 610 is parallel to an axis of the handle housing 100, the adjusting slider 620 is slidably disposed in the receiving cavity 110, the adjusting slider 620 is provided with an external thread engaged with the adjusting nut 610, the handle housing 100 is provided with at least one guide through groove 103, and the internal thread of the adjusting nut 610 and the external thread of the adjusting slider 620 are engaged with each other through the guide through groove 103. In this embodiment, the axis of the adjusting nut 610 and the axis of the adjusting slider 620 are both overlapped with the axis of the handle casing 100, the inner cavity of the adjusting nut 610 is axially provided with a trapezoidal internal thread which is matched and meshed with the trapezoidal external thread provided by the bending slider, when the adjusting nut 610 is rotated, the axis of the adjusting slider 620 handle casing 100 moves towards the near end or the far end, and when the adjusting slider 620 moves towards the near end, corresponding to the pulling rope 800, the sheath tube assembly 400 is bent. When the adjustment slider 620 moves distally, the sheath assembly 400 is restored to a straight state corresponding to the release of the traction rope 800.

In this embodiment, please refer to fig. 2 and fig. 6, the profile of the adjusting slider 620 is substantially cylindrical, and the circumferential wall surface of the adjusting slider 620 is attached to the inner wall surface of the accommodating cavity 110, so as to prevent the adjusting slider 620 from shaking during the sliding process. The direction runs through groove 103 and extends along the axis direction of handle casing 100, the outer peripheral face of adjusting slider 620 still is equipped with direction boss 621, the external screw thread of adjusting slider 620 is located on the direction boss 621, direction boss 621 runs through the groove 103 cooperation with the direction, the effect of direction when playing axial sliding, direction boss 621 must keep unanimous with the quantity that leads and run through groove 103, in this embodiment, the quantity that leads runs through groove 103 is two, use the axis of handle casing 100 to set up as symmetry axis symmetry.

Further, as shown in fig. 3, in order to prevent the adjustment nut 610 from moving axially relative to the handle housing 100, one of the outer wall of the handle housing 100 and the inner wall of the adjustment nut 610 is provided with an annular protrusion 104 provided in the radial direction of the handle housing 100, and the other of the two is provided with a first annular groove 611 into which the annular protrusion 104 is fitted, and the degree of axial freedom of the adjustment nut 610 is limited by the fitting of the annular protrusion 104 into the first annular groove 611. In this embodiment, the annular protrusion 104 is annularly disposed on the outer circumferential surface of the handle housing 100, and the first annular groove 611 is disposed on the inner wall surface of the adjusting nut 610.

In some embodiments, please refer to fig. 2 and 3, the handle casing 100 is provided with a second annular groove 105 disposed along a radial direction of the handle casing 100, the adjusting nut 610 is disposed in the second annular groove 105, and a proximal end and a distal end of the adjusting nut 610 respectively abut against two sidewalls of the second annular groove 105. On one hand, the adjusting nut 610 is arranged in the second annular groove 105, so that the adjusting nut 610 sinks integrally, the outer peripheral surface of the adjusting nut 610 is flush with the outer peripheral surface of the handle shell 100, the whole structure of the atrial septum puncture device is compact, and the appearance is simpler and smoother; on the other hand, the adjustment nut 610 is axially restrained by the two side walls of the second annular groove 105 to limit the axial degree of freedom of the adjustment nut 610. In the present embodiment, the annular protrusion 104 is provided on the bottom wall of the second annular groove 105.

In some embodiments, as shown in fig. 7, the adjusting nut 610 is provided with first scales 612 arranged along the circumferential direction of the adjusting nut 610, the handle housing 100 is provided with second scales 106 corresponding to the first scales 612, and the first scales 612 and the second scales 106 are aligned to display the bending angle of the sheath assembly 400, so that an operator can easily and intuitively know the bending angle of the sheath assembly 400 through the first scales 612 and the second scales 106, so as to accurately and rapidly adjust the sheath assembly 400 to a desired angle, thereby improving the efficiency of the operation.

In some embodiments of the present invention, as shown in fig. 11 and 12, the sheath assembly 400 includes a lining 410, an insulating layer set 420, an electrode assembly 430 and an electrode lead 440, specifically, the sheath assembly 400 is generally tubular, the lining 410 is tubular, an inner diameter of the lining 410 is an inner diameter of the sheath assembly 400, the lining 410 extends from a distal end of the sheath assembly 400 to a proximal end of the sheath assembly 400, and the lining 410 is made of an insulating, non-toxic, biocompatible material with a small friction coefficient, such as Polytetrafluoroethylene (PTFE). The puncture needle 700 is sleeved with the lining 410, the insulation layer group 420= is sleeved with the lining 410, the electrode assembly 430 is arranged on the insulation layer group 420, the distal end of the electrode lead 440 is connected with the electrode assembly 430, and the proximal end of the electrode lead 440 is used for externally connecting a mapping system device. By providing the electrode assembly 430, the electrical signals acquired by the electrode assembly 430 are processed by a mapping system device, so that the sheath assembly 400 can be visualized in a three-dimensional mapping reconstruction heart for use in zero-ray interventional diagnosis and treatment operations.

In this embodiment, a connection plug 130 is further disposed at the proximal end of the handle housing 100, the proximal end of the electrode lead 440 is connected to the connection plug 130, and the mapping system device can be quickly connected to the electrode lead 440 via the connection plug 130.

In an exemplary embodiment, as shown in fig. 11, the insulation layer group 420 includes a first insulation layer 421, a second insulation layer 422 and a third insulation layer 423, the electrode assembly 430 includes a first electrode 431 and a second electrode 432, the first electrode 431 has a tubular structure, an inner diameter of the first electrode 431 is larger than an outer diameter of the liner 410, the first electrode 431 is sleeved on an outer layer of the liner 410, a distal end of the first electrode 431 has a first preset distance from a distal end of the sheath assembly 400, the first preset distance is set to be 5mm in the embodiment, and a proximal end of the first electrode 431 is flush with a proximal end of the liner 410. The first insulating layer 421 is disposed outside the liner 410, and a distal end of the first insulating layer 421 is flush with the liner 410, and a proximal end of the first insulating layer 421 abuts against a distal end of the first electrode 431. The distal end of the first electrode 431 is provided with a first boss structure 4311, and the outer circumferential surface of the first boss structure 4311 forms part of the outer circumferential surface of the sheath assembly 400. The second insulator layer 422 is sleeved over the first electrode 431, the distal end of the second insulator layer 422 starts at the proximal end of the first plateau structure 4311, and the proximal end of the second insulator layer 422 is flush with the proximal end of the liner 410. The distal end of the second insulating layer 422 is provided with a second boss structure 4221, the second boss structure 4221 is arranged adjacent to the first boss structure 4311, and the outer peripheral surface of the second boss structure 4221 forms part of the outer peripheral surface of the sheath tube assembly 400. The second electrode 432 is tubular and is sleeved on the outer layer of the second insulating layer 422, the distal end of the second electrode 432 abuts against the proximal end of the second boss structure 4221, the proximal end of the second electrode 432 is flush with the proximal end of the lining 410, the proximal end of the second electrode 432 is provided with a third boss structure 4321, the third boss structure 4321 is arranged adjacent to the second boss structure 4221, and the outer peripheral surface of the third boss structure 4321 forms part of the outer peripheral surface of the sheath assembly 400. The third insulating layer 423 is disposed outside the second electrode 432, a distal end of the third insulating layer 423 abuts against a proximal end of the third protruding structure 4321, and a proximal end of the third insulating layer 423 is flush with a proximal end of the lining 410. The axial length of the first boss structure 4311 is set to be about 5mm, the axial length of the second boss structure 4221 is set to be about 10mm, and the axial length of the third boss structure 4321 is set to be about 5 mm. Electrode wires 440 are welded to the proximal ends of the first and

second electrodes

431 and 432, respectively, and externally connect the mapping system device, and the electrode wires 440 are used for conducting electrical signals. The first electrode 431 and the second electrode 432 are made of conductive materials, and the materials and the structures of the first electrode 431 and the second electrode 432 can be the same or different, and can adopt a woven mesh tube or a spring structure. The first electrode 431 and the second electrode 432 are separated by the second insulating layer 422, so that the communication between the two electrodes is not interfered with each other, the stability of electric signal conduction is improved, and the structure of the double-layer electrode can enhance the rigidity of the sheath assembly 400 and prevent the middle section of the sheath assembly 400 from being bent. The insulation layer set 420 is made of an insulating, non-toxic, biocompatible material, such as polyether block polyamide (Pebax). The thickness of each part can be adjusted to make the outer diameter of the sheath tube assembly 400 uniform without steps.

In another exemplary embodiment, as shown in fig. 12, insulation layer set 420 includes a support layer 424 and an insulation layer 425, where the support layer 424 and the insulation layer 425 are each tubular structures, and where the inner diameter of the support layer 424 is greater than the outer diameter of the liner 410 and is sleeved over the outer layer of the liner 410. The distal end of the support layer 424 and the distal end of the liner 410 are provided with a second preset distance, in this embodiment, the length of the second preset distance is set to be 5mm, the proximal end of the support layer 424 is flush with the proximal end of the liner 410, and the support layer 424 is mainly used for improving the rigidity of the sheath assembly 400 and preventing the middle section of the sheath assembly 400 from bending. The distal end of the insulating layer 425 is flush with the distal end of the liner 410, the proximal end of the insulating layer 425 is flush with the proximal end of the liner 410, and the insulating layer 425 covers the outer layer of the support layer 424. The electrode assembly 430 includes a first electrode 431 and a second electrode 432, wherein the first electrode 431 and the second electrode 432 are both annular, the first electrode 431 and the second electrode 432 are both sleeved outside the insulating layer 425, and the first electrode 431 and the second electrode 432 are arranged at intervals. The distal end of the electrode lead 440 is encapsulated within the insulating layer 425 and welded to the inner circumferential surfaces of the first electrode 431 and the second electrode 432, respectively, and the proximal end of the electrode lead 440 extends out of the proximal end of the insulating layer 425 and is externally connected to mapping system equipment to conduct electrical signals.

In this embodiment, as shown in fig. 3, 4 and 6, the first linkage assembly 310, the first driving assembly 200, the second linkage assembly 320 and the second driving assembly 600 are sequentially arranged from the proximal end to the distal end along the axial direction of the handle housing 100. Between the first slider 312, the second slider 322 and the adjustment slider 620, the first slider 312 is disposed near the proximal end, the adjustment slider 620 is disposed near the distal end, and the second slider 322 is disposed between the adjustment slider 620 and the first slider 312. The adjustment slider 620 is provided with a first through hole 622. The second slider 322 is provided with a second through hole 3223, and a step structure 32231 is provided on an inner wall of the second through hole 3223. The first slider 312 is provided with a third through hole 3123. The axes of the first through hole 622, the second through hole 3223 and the third through hole 3123 all overlap with the axis of the handle housing 100, and the first through hole 622 is used for avoiding the sheath assembly 400, so that the proximal end of the sheath assembly 400 can pass through the first through hole 622 and is connected and fixed to the step structure 32231 of the second through hole 3223. The second through hole 3223 is used to avoid the puncture needle 700, and the proximal end of the puncture needle 700 can extend to the third through hole 3123 through the second through hole 3223 and be fixed in the third through hole 3123. Wherein, the proximal end side of the first sliding block piece is further provided with an extension rod 3224, the third through hole 3123 extends from the first sliding piece 312 to the extension rod 3224, and the proximal end of the third through hole 3123 forms an opening at the proximal end of the extension rod 3224, the third through hole 3123 is communicated with the inner cavity of the puncture needle 700 to establish a guide wire passage, so that a guide wire can enter from the distal end of the puncture needle 700 and can be extended out through the proximal end of the third through hole 3123. A luer connector 3225 is further disposed on the extension rod 3224, and an inner hole of the luer connector 3225 is penetrated through the third through hole 3123, so as to facilitate operations such as air exhaust and blood drawing when an external instrument is connected thereto in an operation.

Second embodiment

The sheath assembly 400, the puncture needle 700, the handle housing 100, and the second driving assembly 600 in this embodiment are substantially the same as the sheath assembly 400, the puncture needle 700, the handle housing 100, and the second driving assembly 600 in the first embodiment, but the differences are the structures of the first driving assembly 200, the linkage mechanism 300, and the clutch assembly 500, and the differences between the second embodiment and the first embodiment will be described below, and the descriptions of the same or similar parts between the second embodiment and the first embodiment will not be repeated.

In the present embodiment, the linkage mechanism 300 is a slider mechanism with two cranks 330 arranged in opposite directions, and by converting the rotation of the crank 330 into the linear motion of the slider, the first slider 312 serves as one of the sliders, and the second slider 322 serves as a slider to be connected, so that the first slider 312 and the second slider 322 are moved in opposite directions by driving the linkage of the two links.

In detail, as shown in fig. 13, the linkage structure includes a crank 330, a first link 340, a second link 350, a first slider 312 and a second slider 322, and the first slider 312 and the second slider 322 are both slidably engaged with the inner wall of the handle housing 100, so that both the first slider 312 and the second slider 322 can slide relative to the handle housing 100 along the axial direction of the handle housing 100. The crank 330 is rotatably disposed in the accommodating cavity 110, the crank 330 includes a first hinge portion 331 and a second hinge portion 332 which are centrosymmetric, one end of the first link 340 is hinged to the first hinge portion 331, the other end of the first link 340 is hinged to the first sliding member 312, one end of the second link 350 is hinged to the second hinge portion 332, and the other end of the second link 350 is hinged to the second sliding member 322. The first driving assembly 200 includes a transmission rod (not shown) connected to the crank 330, and an adjusting knob 220 connected to the transmission rod and disposed outside the accommodating cavity 110. In the present embodiment, the first hinge portion 331, the first link 340, and the first slider 312 constitute one of the crank 330 slider mechanisms, the second hinge portion 332, the second link 350, and the second slider 322 constitute the other crank 330 slider mechanism, and the two crank 330 slider mechanisms are arranged in central symmetry about the rotation axis of the crank 330, so that the first slider 312 and the second slider 322 move in opposite directions when the crank 330 rotates.

In the present embodiment, the clutch assembly 500 is a connecting member, and the clutch assembly 500 can be detachably connected to the second slider 322 and the handle housing 100, respectively, to change the relative state between the second slider 322 and the handle housing 100. Also, a long hole (not shown) extending in its own axial direction is provided on the handle case 100, and the transmission lever protrudes from the long hole out of the accommodation chamber 110 and can slide therein. When the puncture needle 700 performs a puncturing action, the connecting members are connected with the second slider 322 and the handle housing 100, the second slider 322 is stationary relative to the handle housing 100, and when the adjusting knob 220 is rotated, the second slider 322 remains stationary, and the crank 330 and the first slider 312 can both slide along the axial direction of the handle housing 100 to realize the movement of the first slider 312 and the second slider 322 toward each other, so that the puncture needle 700 can move distally to extend out of the distal end of the sheath assembly 400 while the sheath assembly 400 remains stationary, thereby completing the puncturing action.

When the puncture needle 700 performs a needle threading operation, the second slider 322 can be moved relative to the handle housing 100 by detaching the connector from the second slider 322 and the handle housing 100. By counter-rotating the adjustment knob 220, both the first slider 312 and the second slider 322 are able to move relative to the handle housing 100 to effect a back-to-back movement of the first slider 312 and the second slider 322 to allow the puncture needle 700 to move proximally to complete a retracting motion while the sheath assembly 400 remains distally extended to complete a reaming motion.

It should be noted that the present embodiment is only one possible way of the linkage mechanism 300, and the linkage mechanism 300 may be configured in other forms according to actual requirements, as long as the linkage mechanism 300 includes two modules or structures moving back to back, which are respectively connected to the proximal end of the puncture needle 700 and the proximal end of the sheath assembly 400, and can realize that the proximal end of the sheath assembly 400 and the proximal end of the puncture needle 700 move back to back, which is within the protection scope of the present invention.

A brief surgical procedure of an embodiment of the present invention is as follows: the wiring plug 130 is externally connected with a mapping system device, the mapping system device generates low-energy current and transmits the low-energy current to the electrode assembly 430, and the sheath tube assembly 400 can be visualized in the heart reconstructed by three-dimensional mapping through the calculation of sending signals and recovering signals, so that the sheath tube assembly 400 can realize ray-free operation in the using process. After the sheath assembly 400 is delivered to the right atrium through the guide wire, the adjusting nut 610 on the adjusting handle is rotated to bend the distal end of the sheath assembly 400 to a desired angle and find the position of the interatrial septum, the puncture needle 700 is in a non-ejection state at this time, the position of the positioning button 520 is adjusted to enable the matching piece 510 and the matching part 3221 to be in a first matching state, the adjusting knob 220 is rotated again, the position of the sheath assembly 400 is kept unchanged, the puncture needle 700 extends out of the sheath and abuts against the interatrial septum tissue, and then the adjusting knob 220 is rotated to enable the puncture needle 700 to puncture the interatrial septum and enter the left atrium. The positioning knob 520 is pulled out outwards and rotated by 90 degrees, so that the matching element 510 and the matching part 3221 are in a second matching state, and then the positioning knob 520 is released in the second limiting groove 102, so that the adjusting knob 220 is reversed, and the puncture needle 700 can retreat (i.e. move towards the proximal end side) and extend forwards (i.e. move towards the distal end side), the head of the puncture needle 700 can be completely contracted into the sheath, the needle head can not be contacted with the heart wall, and the risk of puncturing the heart wall is completely avoided.

The interatrial septum puncture device provided by the invention has the following advantages:

firstly, the interatrial septum puncture device structurally combines the sheath tube assembly and the puncture needle, and reduces the process of subsequent split assembly of the puncture needle, so that the risk that the puncture needle scratches the inner wall of the sheath tube assembly to generate scraps is greatly reduced. Meanwhile, the puncture needle and the sheath tube component can move reversely, so that quick needle return and quick reaming can be simultaneously completed through one-step operation.

Secondly, through the mode of gear engagement, screw thread regulation, can make the extended position of pjncture needle and the distance that stretches out accurate, controllable, avoid among the existing equipment doctor because inertia effect when pushing the pjncture needle by hand gets into left atrium after crossing the interatrial septum, the pjncture needle continues to move forward and pierces left atrium wall, causes the pericardium to fill, or pierces the aorta and causes serious complication etc. harm patient's situation emergence.

And thirdly, the bending angle of the sheath pipe assembly can be accurately adjusted through the second driving assembly by using the traction rope, so that the puncture angle of the puncture needle is adjusted, the puncture needle does not need to be withdrawn, the angle is formed again for the puncture needle, the position precision of the puncture needle is improved, and the operation time is saved.

Fourthly, the sheath assembly can be visualized in the heart reconstructed by three-dimensional mapping, is suitable for zero-ray interventional diagnosis and treatment operation, and enables a doctor to accurately judge whether the sheath assembly passes through the interatrial space and the depth of the sheath assembly passing through the interatrial space.

While the invention has been described with reference to specific preferred embodiments, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention as defined in the following claims. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. An interatrial septum puncture device, comprising:

a handle housing having an accommodating cavity;

2. The interatrial septum penetration device of claim 1, wherein said linkage further comprises:

the second linkage assembly is connected with the first driving assembly;

3. The transseptal puncture device of claim 2, further comprising:

the clutch component and the second linkage component have a first matching state and a second matching state,

4. The transseptal puncture device of claim 3,

the first linkage assembly includes:

the second linkage assembly includes:

5. The transseptal puncture device of claim 4,

the first driving assembly comprises a driving gear, and the first sliding piece is provided with a first threaded hole;

the first transmission assembly comprises a first driven gear and a first screw rod which are connected, the first screw rod penetrates through the first threaded hole and is matched with the first threaded hole, and two ends of the first screw rod are respectively connected with the handle shell in a rotatable mode;

and in the second matching state, the transmission nut is connected with the matching part through the matching piece.

6. The transseptal puncture device of claim 5,

the matching part is a deformable claw structure, and the claw structure is provided with a matching hole;

under the second cooperation state, the pin part is separated from the cooperation hole, and the claw structure clamps the transmission nut.

7. The transseptal puncture device of claim 5,

the ratio of the number of teeth of the first driven gear to the number of teeth of the second driven gear is greater than or equal to 1; and/or

The ratio of the pitch of the second screw to the pitch of the first screw is greater than or equal to 1.

8. The transseptal puncture device of claim 6,

the clutch assembly further comprises a positioning button, a connecting rod and an elastic piece, the positioning button is positioned outside the accommodating cavity, one end of the connecting rod is connected with the positioning button, the other end of the connecting rod extends into the accommodating cavity and is connected with the matching piece, the elastic piece is sleeved on the connecting rod, one end of the elastic piece abuts against the matching piece, and the other end of the elastic piece abuts against the inner wall of the accommodating cavity;

9. The transseptal puncture device of claim 8,

the outer wall of the handle shell is provided with a first limiting groove and a second limiting groove which are sunken towards the matching part, the position of the positioning button can be switched between the first limiting groove and the second limiting groove, and the depth of the first limiting groove is greater than that of the second limiting groove;

10. The transseptal puncture device of any of claims 1-9,

the sheath assembly includes:

the lining is sleeved outside the puncture needle;

the insulation layer group is sleeved outside the lining;

an electrode assembly provided in the insulating layer group;

11. The transseptal puncture device of claim 10,

the insulation layer group comprises a first insulation layer, a second insulation layer and a third insulation layer;

the electrode assembly includes a first electrode and a second electrode;

12. The transseptal puncture device of claim 10,

the insulation layer group comprises a supporting layer and an insulation layer, the supporting layer is sleeved outside the lining, and the insulation layer is sleeved outside the supporting layer;